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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K000982
Device Name A100 AESTHETIC DIODE LASER
Applicant
Diomed, Inc.
1 Wing Rd.
Lynnfield,  MA  01940
Applicant Contact MAUREEN O'CONNELL
Correspondent
Diomed, Inc.
1 Wing Rd.
Lynnfield,  MA  01940
Correspondent Contact MAUREEN O'CONNELL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/27/2000
Decision Date 05/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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